RETR(Osteomyelitis)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- site of osteomyelitis
研究概览
简要总结
This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.
详细描述
Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with the risk of fracture and amputation. It is caused by the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess. Chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery.
Despite the progress made in both antibiotics and surgical treatment, the probability of failure of this treatment (infectious recurrence) is of the order of 20%, and has unfortunately remained stable for more than 20 years.
An innovative treatment, Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin (CE marking), fills the "dead space" which is formed during surgery, prevents this cavity filled with blood from becoming infected, and promotes the regeneration of the bone within this space, limiting the risk of fracture in the medium and long term. It also locally delivers very high doses of gentamicin for several weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who presented with osteomyelitis between 2017 and 2021
排除标准
- •Patients who objected to participating in the study
结局指标
主要结局
site of osteomyelitis
时间窗: between 2017 and 2021
localisation
rate of patient treated with CERAMENT
时间窗: between 2017 and 2021
proportion of patients having had CERAMENT
rate of osteomyelitis in BJI
时间窗: between 2017 and 2021
proportion of patients having had an osteomyelitis
type of osteomyelitis
时间窗: between 2017 and 2021
hematogenous or after a trauma or after a surgery
Description of the follow up of the patients
时间窗: between 2017 and 2021
duration of the follow up of patients
rate of treatment failure
时间窗: between 2017 and 2021
treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
rate of bacteria involved in osteomyelitis
时间窗: between 2017 and 2021
description of bacteria responsible for osteomyelitis
description of patients : medical treatment
时间窗: between 2017 and 2021
description and duration of antibiotics
bone defect size
时间窗: between 2017 and 2021
dimension of the bone defect size
Description of patients
时间窗: between 2017 and 2021
comorbidities, age
Description of patients : surgical treatment
时间窗: between 2017 and 2021
description of surgery performed
次要结局
未报告次要终点